DARWIN EU® - Background rates of serious adverse events to contextualise safety assessments in clinical trials and non-interventional studies in adolescent and adult patients with severe asthma

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104146
• EU PAS number:
  EUPAS103936
• Study ID:
  104146
• Official title and acronym:
  DARWIN EU® - Background rates of serious adverse events to contextualise safety assessments in clinical trials and non-interventional studies in adolescent and adult patients with severe asthma
• DARWIN EU® study:
  Yes
• Study countries:
  Estonia

  Netherlands

  Spain

  United Kingdom
• Study description:
  During the evaluation of the safety results of a clinical trial in patients with severe asthma, differences in rates of serious adverse events were observed in the experimental treatment arm compared to the control arm. In order to contextualize these differences, a non-interventional study was requested to generate background rates of selected health outcomes in patients with severe asthma, with a disease definition that follows recently conducted clinical trials. ; By means of a retrospective cohort study using routinely-collected health data from 5 databases we will investigate the following: (i) To estimate the rate of mortality due to any cause stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. (ii) To estimate the rate of mortality due to fatal infections stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. (iii) To estimate the rate of mortality due to cardiovascular events stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. (iv) To estimate the incidence rate of serious cardiovascular events (but not necessarily leading to death) stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2022), sex, age and country/database. ; The study population will consists of all individuals present in the database in the period between 01/01/2015 and 31/12/2022, with at least 1 year of prior history, being diagnosed with severe asthma and fulfilling inclusion and exclusion criteria. ; The study period is from 2015-2022. Variables of interest will consist of outcomes, comorbidity, lifestyle factors, measurements and drug exposure data. Participating databases have their data mapped to the OMOP CDM. Participating databases are SIDIAP, IPCI, CPRD Gold, IMASIS and the Estonian Biobank.
• Study status:
  Finalised

Research institution and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Parc de Salut Mar Barcelona (PSMAR)

Spain

University of Tartu

Estonia

Oxford University, UK

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Hungary

Netherlands

Norway

Portugal

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 19/12/2022

Actual: 19/12/2022

Study start date

Planned: 01/01/2015

Actual: 01/01/2015

Date of final study report

Planned: 01/05/2023

Actual: 17/11/2023

Sources of funding

EMA

EU institutional research programme

Study protocol

Initial protocol

D2.2.3_DARWIN_EU_Study_Protocol_C3-001_V4.0

Updated protocol

D2.2.3_DARWIN_EU_Study_Protocol_C3-001_V4.1

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable